A systematic approach to improve the initial success rates of bioanalytical assay transfers to contract research organizations

As outsourcing has become mainstream in the bioanalytical industry, sponsor organizations commonly develop bioanalytical assays in-house before transferring them to contract research organizations (CROs) for validation and sample testing. However, bioanalytical assay transfer processes represent one of the most challenging workflows and can consume substantial resources in terms of personnel, time, and cost. We developed and implemented a systematic approach to enhance bioanalytical assay quality and transfer efficiency, significantly reducing transfer and troubleshooting time while improving overall success rates.